BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA HP UNI FEMORAL SZ5 LM/RL

    MDR report key: 1972426 · Received January 26, 2011

    Report

    Report Number
    1818910-2011-01165
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    December 30, 2010
    Report Date
    December 30, 2010
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    NPJ
    PMA / PMN Number
    K070849
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER ADD'L REPORTS AGAINST THE LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE PRODUCT TO EXAMINE. PROVIDED INFO STATED THE CEMENT TECHNIQUE WAS A CONTRIBUTING FACTOR AND THE PRODUCT WAS NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS OR BEING A CONTRIBUTING FACTOR TO THE EVENT. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS FEMORAL LOOSENING DUE TO POOR CEMENT TECHNIQUE. THE IMPLANT ONLY HAD CEMENT ON THE POSTERIOR SURFACE. THE PEGS WERE CLEAN. THE CEMENT REMAINED BONDED TO THE BONE. DEPUY CEMENT WAS USED AT THE TIME OF IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA HP UNI FEMORAL SZ5 LM/RL 87NPJ; 87HRY NPJ DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA C4GD94000

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention